Trevi Therapeutics NASDAQ: TRVI management used the company’s first-quarter 2026 earnings call to outline upcoming clinical milestones for its chronic cough programs and to highlight an expanded cash runway following an April equity offering.
Clinical program updates and upcoming trial starts
President and CEO Jennifer Good said 2026 is “an important year of execution,” and noted the company is preparing to advance multiple studies across idiopathic pulmonary fibrosis (IPF)-related chronic cough, non-IPF interstitial lung disease (ILD)-related chronic cough, and refractory chronic cough (RCC).
Following what Good described as a positive FDA meeting in the first quarter to align on the company’s IPF-related chronic cough program, Trevi finalized protocols for two Phase 3 trials and has been identifying global trial sites. Good said the company expects to initiate the first of the two Phase 3 studies in the current quarter, with the second slated to begin in the second half of 2026.
For non-IPF ILD-related chronic cough, Good said the company plans to request another FDA meeting and submit a protocol to discuss an adaptive Phase 2/3 study design. The company intends to use the Phase 2 portion to confirm dose and assumptions before transitioning into a single pivotal Phase 3 study intended to support approval. If aligned with FDA, Good said Trevi expects to start that trial in the second half of the year. She added that the non-IPF ILD population is expected to resemble the IPF study population, and that the company is planning operationally so it can “act quickly once we have alignment with the FDA on the protocol.”
On the call, Chief Development Officer James Cassella said the FDA discussion is designed to review Trevi’s intention to use the adaptive Phase 2/3 program in an “sNDA strategy.” Cassella said the company will seek to align on the patient population, dose selection confirmation, and an interim analysis intended to validate power assumptions for the Phase 3 component.
In RCC, Good said Trevi expects to initiate a Phase 2b parallel-arm dose-ranging study this quarter that will include three dose levels plus placebo. The finalized protocol has been submitted to regulatory authorities, and the company is qualifying sites, she said.
RCC design considerations and placebo response
Cassella said the RCC Phase 2b includes a sample size re-estimation (SSRE) planned when 50% of patients complete the trial, with an SSRE readout expected in the fourth quarter of 2026. In response to analyst questions, Cassella said the SSRE will evaluate conditional power, targeting 80%. If conditional power is below 80%, the company would increase sample size proportionately, he said, while a futility threshold would be “down in that 30%-40% range.”
Asked about mitigating placebo response in RCC, Cassella pointed to Trevi’s prior CORAL study in IPF, which he said showed an “under 20% placebo response,” and added that placebo response can be more variable in RCC. He said Trevi is seeking to control for factors that can contribute to placebo response through trial conduct and includes a placebo run-in period, based on input from experts in the RCC space, to look for stability in cough response.
Cassella also addressed patient eligibility in RCC in the context of potential prior exposure to P2X3 antagonists, saying patients who meet eligibility requirements and have been off a P2X3 therapy for an appropriate time period could enroll.
Competitive landscape and commercial positioning
Chief Commercial Officer Farrell Simon addressed questions about the competitive landscape in RCC, including anticipated data from camlipixant. Simon said Trevi is “hoping that they are successful,” calling RCC a large unmet-need population that could support multiple modalities. He said Trevi believes it has “strong differentiation with our central and peripheral mechanism of action,” and that the company plans to discuss positioning at its upcoming Investor Day.
Simon added that if camlipixant is unsuccessful, the company would reassess competitive positioning while still viewing the market as a “large unmet need.” Cassella said investigators are enthusiastic and that enrollment interest remains strong regardless of outcomes in the broader environment.
Good said Trevi’s RCC Phase 2b will likely complete before any competitor’s product could be approved, and suggested competitive dynamics could become more relevant during a potential Phase 3 stage. In another discussion about P2X3 programs, Good said Trevi would be interested in learning about placebo control approaches, but she did not expect competitors’ results to materially change Trevi’s plan. She noted that some P2X3 programs have used more restrictive enrollment approaches and placebo run-ins, while Trevi has “shown data that our drug works broadly in IPF chronic cough and refractory chronic cough across different cough counts.”
Separately, Good addressed questions about how increased use of inhaled therapeutics in IPF and progressive pulmonary fibrosis could influence the opportunity for Trevi’s therapy, noting that Trevi is targeting chronic cough that is “more systemic” and that the interaction between hypersensitization and inhaled products “is something that’s gonna have to be learned over time.” She said the company has been conducting drug-drug interaction studies and expects to be able to be used alongside other therapies.
ATS data, dyspnea, and additional analyses
Good highlighted that Trevi will be active at the American Thoracic Society (ATS) meeting, where the company had all six submissions accepted for presentations or posters. Cassella previewed several data areas expected at the conference, including new sub-analyses from the CORAL study in an oral presentation by Dr. Philip Molyneaux, analysis of “cough bouts” from CORAL and RIVER, and “breathlessness data” presented by Don Mahler.
Simon said the company’s research with physicians and payers indicates dyspnea is among the top three complaints for IPF and ILD patients, alongside cough and fatigue. While he said it does not change the company’s commercial thesis, he believes it could complement uptake and adoption, and could help in payer discussions by supporting “additional value.”
In response to a question about forced vital capacity (FVC), Cassella said Trevi will track FVC at baseline and throughout the 52-week Phase 3 period, but emphasized that FVC is highly variable and not central to the company’s trial endpoints. “All I can promise you is that we will see what we see and report it out,” he said.
Cash runway and IP portfolio updates
Chief Financial Officer David Hastings said Trevi ended the first quarter of 2026 with approximately $172 million in cash, cash equivalents, and marketable securities, excluding $162 million in net proceeds from an underwritten common stock offering completed in April 2026. Hastings said the offering was “well-received,” and that the financing removed “any financial overhang” heading into key clinical endpoints and extended cash runway into 2030.
Hastings said the company’s runway guidance includes funding for the IPF-related chronic cough development program, “potentially through FDA approval.” He said cash resources are expected to also enable Trevi to fund and report top-line data from the planned Phase 2b trial and potentially a subsequent Phase 3 trial in non-IPF ILD-related chronic cough, and to fund the planned Phase 2b trial in RCC. He added that planned spending includes pre-commercial activities, but not expenses related to a commercial launch of Haduvio or any additional clinical trials.
On intellectual property, Good said Trevi’s “core method of treatment patent” for IPF-related chronic cough was issued in Europe during the quarter, and that the patent had already been issued in the U.S., providing protection through 2039. She said Trevi filed additional applications in the U.S. this year which, if issued, could extend coverage through 2046. Good also described a strategy to pursue additional patents tied to expected label elements, including titration schedule and dosing adjustments, and noted that ongoing Phase 1 work can be “quite rich for IP.”
Looking ahead, Good pointed investors to a May 7 Investor and Analyst Day where the company plans to discuss upcoming trial details, projected timelines, additional analyses of existing clinical data, and commercial learnings from market research, along with input from key opinion leaders. Trevi also plans an investor analyst event at ATS on May 18 featuring Cassella and Dr. Molyneaux to summarize data presented at the conference.
About Trevi Therapeutics NASDAQ: TRVI
Trevi Therapeutics, Inc is a clinical-stage biopharmaceutical company focused on the development of novel non-opioid therapies for the management of chronic and acute pain. The company leverages proprietary drug delivery platforms and targeted molecular approaches to address high unmet needs in cancer-related pain, chemotherapy-induced neuropathy and other severe pain conditions.
Its lead product candidate is a proprietary formulation of tetrodotoxin (TTX), a sodium-channel blocking agent being evaluated in early-stage clinical trials for moderate-to-severe pain associated with advanced cancer and peripheral neuropathy.
Further Reading
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